Biocon’s fully integrated global biosimilars company and subsidiary -- Biocon Biologics (BBL) has received Health Canada approval, a Notice of Compliance (NOC), for Yesintek (ustekinumab injection) and Yesintek I.V. (ustekinumab for injection, solution for intravenous infusion), a biosimilar to Stelara (ustekinumab injection) and Stelara I.V. (ustekinumab for injection, solution for intravenous infusion). The approval was granted on October 17, paving the way for Canadian commercial availability in mid-October.
Yesintek and Yesintek I.V. are indicated for the treatment of moderate to severe plaque psoriasis in adult patients and in pediatric patients (6-17 years of age), active psoriatic arthritis in adults, moderately to severely active Crohn’s disease and ulcerative colitis in adults-a range of debilitating autoimmune conditions that affect thousands of Canadians.
Health Canada approval was based on a comprehensive data package, confirming that Yesintek is highly similar to Stelara with no clinically meaningful differences in efficacy, safety and immunogenicity. Yesintek will be available through the My Biocon Biologics patient support program, which provides assistance to individuals prescribed with the therapy. Yesintek is available as a subcutaneous injection, 45 mg/0.5ml (prefilled syringe and vial) and 90 mg/ml (prefilled syringe) and Yesintek I.V. as an intravenous solution, 130 mg/26mL (5mg/mL).
Biocon is India’s largest and Asia’s leading Biotechnology Company with a strategic focus on biopharmaceuticals and research services. It is a fully integrated, innovation driven biopharma enterprise offering affordable solutions for chronic diseases to patient's worldwide.
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